Myopia Prevention Through Monitoring and Motivating Outdoor Activities With Smartwatches

Myopia, Progressive Clinical Trial

Official title:

A Multi-center Clinical Study on the Myopia Prevention by Monitoring and Motivating Outdoor Activities With Smartwatches

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05760911
• Other study ID #: kjb-wb-v1.1-20220507
• Status: Not yet recruiting
• Phase: N/A
• Start date: March 15, 2023
• Est. completion date: September 30, 2024

Study information

• Verified date: March 2023
• Source: Shanghai Eye Disease Prevention and Treatment Center
• Contact: Haidong Zou, MD
• Phone: 02153555032
• Email: zouhaidong[@]sjtu.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The goal of this multi-center, randomized, parallel-controlled clinical trial is to evaluate the effectiveness of outdoor activities monitoring and motivating by smartwatches to prevent myopia progression in children. The main question it aims to answer are:

1. To evaluate the two-year change of spherical equivalent progression.

2. To evaluate the change in axial length, the incidence of myopia, the time of outdoor activity, the choroid thickness, and blood flow through the two-year intervention.

Participants will wear smartwatches and receive Mini Program outdoor activity reminders and motivations. The required outdoor activity time is 2 hours from Monday to Friday and more than 2 hours on weekends. The control group will only wear smartwatches for monitoring. Researchers will compare the control group and the intervention group to see if outdoor activities can protect myopia or not.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 1200
• Est. completion date: September 30, 2024
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 4 Years to 9 Years

Eligibility

Inclusion Criteria:

1. Gender is not limited;

2. Age: 4 ~ 9 years old;

3. Spherical equivalent: -0.5D < SE < 2.5D;

4. Be able to follow up for at least 2 years;

5. Be able to wear a smartwatch on a daily basis as required;

6. Parents or guardians sign an informed consent form;

7. Children over 6 years old need oral consent to participate.

Exclusion Criteria:

1. Anisometropia > 1.50D;

2. Using other interventions for controlling myopia including atropine, rigid orthokeratology lenses, bifocal lenses or progressive lenses, red light, acupuncture, etc.;

3. Strabismus and/or amblyopia;

4. Previous history of eye surgery (including strabismus correction);

5. Ocular or systemic diseases that may be related to the development of myopia or myopia: such as Marfan syndrome, neonatal retinopathy, diabetes, etc.;

6. Other circumstances that the investigator judges inappropriate to participate in the trial.

Related Conditions & MeSH terms

• Myopia
• Myopia, Degenerative
• Myopia, Progressive

Intervention

Behavioral:
• Outdoor activities motivation with smartwatches
Wearing a smartwatch and receiving outdoor activity reminders and encouragement through a mini-program. The required outdoor time is at least 2 hours from Monday to Friday, and more than 2 hours on weekends.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Shanghai Eye Disease Prevention and Treatment Center	Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The change of spherical equivalent	The mean change of spherical equivalent after cycloplegia was calculated during the study.	Two years
Secondary	The change of axial length	The mean change of axial length by IOL Master was calculated during the study.	Two years